FDA.reportPublic FDA data

Anmuth Medical International

Primary DI
08403207009609
Brand
Anmuth Medical International
Company
Anmuth Medical International, LLC
Model
39-221-01
Catalog number
39-221-01
Device description
CASPAR Verterbral Distractor Drill Guide Left
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08403207009609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08403207009609084032070096098403207009609

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(413)478-9876marc@anmuthmedical.com

Regulatory Flags#

DUNS number
786500830
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08403207010032Anmuth Medical International39-539-0339-539-032025-06-09
08403207009500Anmuth Medical International39-110-0039-110-002025-06-09
08403207009517Anmuth Medical International39-112-0039-112-002025-06-09
08403207009524Anmuth Medical International39-138-0039-138-002025-06-09
08403207009579Anmuth Medical International39-172-0039-172-002025-06-09
08403207009647Anmuth Medical International39-311-2039-311-202025-06-09
08403207009807Anmuth Medical International39-525-0639-525-062025-06-09
08403207010162Anmuth Medical International39-546-54TC39-546-54TC2025-06-09
08403207010179Anmuth Medical International39-547-24TC39-547-24TC2025-06-09
08403207010261Anmuth Medical International39-557-2539-557-252025-06-09
08403207010278Anmuth Medical International39-559-40TC39-559-40TC2025-06-09
08403207010285Anmuth Medical International39-559-47TC39-559-47TC2025-06-09
08403207010292Anmuth Medical International39-560-57TC39-560-57TC2025-06-09
08403207010346Anmuth Medical International39-630-0039-630-002025-06-09
08403207010353Anmuth Medical International39-633-2039-633-202025-06-09
08403207010360Anmuth Medical International39-635-1739-635-172025-06-09
08403207010377Anmuth Medical International39-650-2339-650-232025-06-09
08403207010384Anmuth Medical International39-666-0639-666-062025-06-09
08403207009531Anmuth Medical International39-160-0039-160-002025-06-05
08403207009548Anmuth Medical International39-161-1339-161-132025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525324Onyx 6.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525348Onyx 4.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525355Onyx 5.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525362Onyx 6.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525379Onyx 7.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
00810055525393Onyx Straight ProbeSi-Bone Inc.LXH2026-09-29
00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29
00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
00810055525461Onyx Counter TorqueSi-Bone Inc.LXH2026-09-29
00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29